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Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome

Primary Purpose

Chronic Fatigue Syndrome, Myalgic Encephalomyelitis

Status
Terminated
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Etanercept
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring Chronic fatigue syndrome, CFS, Myalgic Encephalomyelitis (ME), CFS/ME, Tumor necrosis factor-alpha, TNF-alpha, Etanercept

Eligibility Criteria

18 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME)
  • moderate and serious CFS/ME severity
  • age 18-66 years
  • informed consent

Exclusion Criteria:

  • patients with fatigue, not fulfilling criteria for CFS
  • pregnancy or lactation
  • previous malignant disease, except basal cell carcinoma of skin and cervical carcinoma in situ
  • previous long-term systemic treatment with immunosuppressive drugs such as cyclosporine, azathioprin, mycophenolate mofetil, except steroids e.g. in obstructive lunge disease.
  • demyelinating disease, such as multiple sclerosis.
  • heart failure.
  • endogenous depression.
  • lack of ability to comply to the protocol.
  • multi-allergy with risk of serious drug reaction
  • reduced renal function (creatinine > 1.5 x UNL)
  • reduced liver function (bilirubin or transaminases > 1.5 x UNL)
  • HIV positivity. Evidence of clinically significant infection. Previous viral hepatitis with risk of reactivation. High risk of opportunistic infections. Latent tuberculosis must be treated before inclusion.

Sites / Locations

  • Dept. of Oncology and Medical Physics, Haukeland University Hospital Bergen, Norway

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Etanercept

Arm Description

Outcomes

Primary Outcome Measures

Symptom alleviation within 12 months follow-up, as compared to baseline, measured by standardized self-reports and quality of life schemes.
The primary endpoint is defined as moderate or major response of the CFS/ME symptoms, of at least six weeks duration, independent on when during 12 months follow-up the response period(s) occurs. Single such response periods, and the sum of these, are recorded.

Secondary Outcome Measures

Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.
The secondary outcome measures are effect on the CFS/ME symptoms, by evaluation at 3, 6, 9, 12 months after start of intervention.

Full Information

First Posted
November 8, 2012
Last Updated
November 30, 2015
Sponsor
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01730495
Brief Title
Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome
Official Title
Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Moderate and Serious Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (CFS/ME), Including in Patients With no Clinical Response After B-lymphocyte Depletion Using the Anti-CD20 Antibody Rituximab.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
After inclusion of four patients, two experienced moderate worsening of symptoms
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The hypothesis is that a subset of patients with chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME), including also patients with no clinical response after B-cell depletion therapy using the anti-CD20 antibody Rituximab, may benefit from tumor necrosis factor-alpha inhibition using Etanercept as weekly subcutaneous injections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
Keywords
Chronic fatigue syndrome, CFS, Myalgic Encephalomyelitis (ME), CFS/ME, Tumor necrosis factor-alpha, TNF-alpha, Etanercept

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Etanercept
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Etanercept
Intervention Description
Weekly subcutaneous injections of Etanercept 50 mg, for up to 12 months.
Primary Outcome Measure Information:
Title
Symptom alleviation within 12 months follow-up, as compared to baseline, measured by standardized self-reports and quality of life schemes.
Description
The primary endpoint is defined as moderate or major response of the CFS/ME symptoms, of at least six weeks duration, independent on when during 12 months follow-up the response period(s) occurs. Single such response periods, and the sum of these, are recorded.
Time Frame
Response of at least six weeks duration, independent on when occuring, during 12 months follow-up.
Secondary Outcome Measure Information:
Title
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.
Description
The secondary outcome measures are effect on the CFS/ME symptoms, by evaluation at 3, 6, 9, 12 months after start of intervention.
Time Frame
At 3, 6, 9, 12 months after start of intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME) moderate and serious CFS/ME severity age 18-66 years informed consent Exclusion Criteria: patients with fatigue, not fulfilling criteria for CFS pregnancy or lactation previous malignant disease, except basal cell carcinoma of skin and cervical carcinoma in situ previous long-term systemic treatment with immunosuppressive drugs such as cyclosporine, azathioprin, mycophenolate mofetil, except steroids e.g. in obstructive lunge disease. demyelinating disease, such as multiple sclerosis. heart failure. endogenous depression. lack of ability to comply to the protocol. multi-allergy with risk of serious drug reaction reduced renal function (creatinine > 1.5 x UNL) reduced liver function (bilirubin or transaminases > 1.5 x UNL) HIV positivity. Evidence of clinically significant infection. Previous viral hepatitis with risk of reactivation. High risk of opportunistic infections. Latent tuberculosis must be treated before inclusion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Øystein Fluge, MD, PhD
Organizational Affiliation
Dept. of Oncology and Medical Physics, Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Oncology and Medical Physics, Haukeland University Hospital Bergen, Norway
City
Bergen
ZIP/Postal Code
N-5021
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
22039471
Citation
Fluge O, Bruland O, Risa K, Storstein A, Kristoffersen EK, Sapkota D, Naess H, Dahl O, Nyland H, Mella O. Benefit from B-lymphocyte depletion using the anti-CD20 antibody rituximab in chronic fatigue syndrome. A double-blind and placebo-controlled study. PLoS One. 2011;6(10):e26358. doi: 10.1371/journal.pone.0026358. Epub 2011 Oct 19.
Results Reference
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PubMed Identifier
19566965
Citation
Fluge O, Mella O. Clinical impact of B-cell depletion with the anti-CD20 antibody rituximab in chronic fatigue syndrome: a preliminary case series. BMC Neurol. 2009 Jul 1;9:28. doi: 10.1186/1471-2377-9-28.
Results Reference
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Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome

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